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Section 904(a)(3) of the Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act, (FDCA) requires manufacturers and importers to report the quantities of Harmful and Potentially Harmful Constituents (HPHCs) found in their tobacco products, or in the smoke produced by their products, by brand and sub-brand.  21 U.S.C. § 387d(a)(3).  This requirement was extended to all deemed products such as e-cigarettes, e-liquid, cigars, hookah and pipe tobacco when the Deeming Rule went into effect on August 8, 2016.

Pursuant to the initial compliance policy set forth in the Deeming Rule, HPHC reports for all deemed finished tobacco products on the market at that time were due by August 8, 2019.  Not long after soon-to-be-departing FDA Commissioner Dr. Scott Gottlieb began his term in 2017, FDA announced that it would be delaying several compliance dates, including the HPHC reporting deadline, by three months to November 8, 2019 for all deemed products.  Since then, FDA has failed to provide any actual guidance on which HPHCs should be assessed and how.  Now, FDA has published a Revised Guidance for Industry: Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule that further extends the reporting deadline for deemed finished tobacco products to a date to be determined in the future depending on when FDA publishes its final guidance on the HPHC reporting requirement (the “Final HPHC Guidance”).  Specifically, HPHC reports for deemed products are now due either nine (9) months after the Final HPHC Guidance is published for small tobacco product manufacturers, or six (6) months after the Final HPHC Guidance is published for large tobacco product manufacturers.  Importantly, FDA has indicated that here a small tobacco product manufacturer is any company (including any entity that it controls, is controlled by, or is under common control with) that has fewer than 350 employees pursuant to Section 900(16) of the FDCA, 21 U.S.C. § 387(16). 

In 2012, FDA finalized a list of 93 HPHCs, focusing on five disease outcomes: cancer, cardiovascular disease, respiratory effects, developmental or reproductive effects, and addiction.  See 77 Fed. Reg. 20034 (Apr. 3, 2012).  When this list was published, only cigarettes, smokeless tobacco and roll-your-own tobacco products were regulated by FDA.  In recognition of testing limitations, laboratory capacity concerns, and the short time between the establishment of the HPHC list and the reporting deadline, rather than require manufacturers to test for and report on all 93 HPHCs, FDA published a guidance document identifying abbreviated lists of representative HPHCs for which testing methods were well established for each of the product categories (cigarettes, roll-your-own, and smokeless tobacco).  FDA also extended the compliance date by 6 months for small tobacco product manufacturers and by 3 months for large tobacco product manufacturers.

Abbreviated List of HPHCs for Traditional Tobacco Products
HPHCs in Cigarette Smoke HPHCs in Smokeless Tobacco HPHCs in Roll-your-own Tobacco and Cigarette Filler
Acetaldehyde Acetaldehyde Ammonia
Acrolein Arsenic Arsenic
Acrylonitrile Benzo[a]pyrene Cadmium
4-Aminobiphenyl Cadmium Nicotine (total)
1-Aminonaphthalene Crotonaldehyde NNK
2-Aminonaphthalene Formaldehyde NNN
Ammonia Nicotine (total and free)
Benzene 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK)
Benzo[a]pyrene N-nitrosonornicotine (NNN)
1,3-Butadiene
Carbon monoxide
Crotonaldehyde
Formaldehyde
Isoprene
Nicotine (total)
NNK
NNN
Toluene

With respect to deemed products, other than broadening the definition of an HPHC to include chemicals in the “aerosol (vapor) or any other emission” that may be potentially inhaled, ingested, or absorbed into the body, FDA has not yet provided any meaningful guidance (or initiated rulemaking) to help companies meet the reporting requirement.

For vapor products, potential HPHCs of interest to FDA may be found in the draft guidance document on Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS) that was published in May 2016 along with the final Deeming Rule.  In that guidance, and in the context of developing PMTAs, FDA identified 29 constituents, along with “other chemicals and toxic chemicals as appropriate,” that it recommends ENDS manufacturers analyze in the aerosol produced by their products (see pages 26-27).  Other than a handful of substances, e.g., acetyl propionyl, diacetyl, diethylene glycol, ethylene glycol, glycerol, menthol, propylene glycol, all of the below substances are also on FDA’s official 93 HPHC list:

FDA PMTA Draft Guidance Analyte List for ENDS
Acetaldehyde (CASRN 75-07-0) 2-Aminonaphthalene (CASRN 91-59-8) Cadmium (CASRN 7440-43-9) Formaldehyde (CASRN 50-00-0) Nicotine, including total nicotine and unprotonated nicotine (CASRN 54-11-5)
Acetyl Propionyl (CASRN 600-14-6) Ammonia (CASRN 7664-41-7) Chromium (CASRN 7440-47-3) Glycerol (CASRN 56-81-5) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) (CAS Reg. No. 64091-91-4)
Acrolein (CASRN 107-02-8) Anabasine (CASRN 494-52-0) Crotonaldehyde (CASRN 4170-30-3) Isoprene (CASRN 78-79-5) N-nitrosonornicotine (CASRN 16543-55-8)
Acrylonitrile (CASRN 107-13-1) Benzene (CASRN 71-43-2) Diacetyl (CASRN 431-03-8) Lead (CASRN 7439-92-1) Propylene glycol (CASRN 57-55-6)
4-Aminobiphenyl (CASRN 92-67-1) Benzo[a]pyrene (CASRN 50-32-8) Diethylene glycol (CASRN 111-46-6); Menthol (CASRN 1490-04-6)

Toluene

(CASRN 108-88-3)

1-Aminonaphthalene (CASRN 134-32-7) 1,3-Butadiene (CASRN 106-99-0) Ethylene glycol (CASRN 107-21-1) Nickel (CASRN 7440-02-0) Other chemicals and toxic chemicals as appropriate (e.g., potentially toxic pyrolytic products of the chemicals listed above)

Of relevance, in Footnote 28 of the draft PMTA guidance FDA states (emphasis added):

These constituents are constituents that, to FDA’s current thinking, potentially could cause health hazards depending on the level, absorption, or interaction with other constituents. FDA intends to establish a revised list of harmful and potentially harmful constituents (HPHCs) that include HPHCs in ENDS products in the Federal Register, issue guidance regarding constituent reporting (i.e., harmful or potentially harmful constituent (HPHC) reporting) under section 904(a)(3) of the FD&C Act, and later issue a testing and reporting regulation as required by section 915. While applicants should submit certain information about HPHCs as part of their applications, the requirement to submit HPHC listings under section 904 of the FD&C Act (21 U.S.C. 387d) is separate and distinct from the premarket review requirements under section 910. HPHC information submitted under section 904 will assist FDA in assessing potential health risks and determining if future regulations to address a product’s health risks are warranted. For PMTAs, FDA expects that applicants will report the levels of HPHCs as appropriate for each product, so the reported HPHCs will differ among different product categories. The Agency recommends that manufacturers consult with CTP’s Office of Science about what is appropriate in the context of a specific application.

For manufacturers of deemed products seeking to comply with the HPHC requirement, critical areas remain unclear, including (1) which HPHCs must be assessed, (2) whether such HPHCs will need to be identified in the e-liquid or tobacco itself or in the vapor/aerosol/smoke produced (particularly for open-system products), (3) what analytical methodologies and testing equipment should be used, and (4) the number of appropriate test samples and replicates, among other things. These are all issues that should be addressed in FDA’s Final HPHC Guidance, which could take several more months or longer to be finalized (especially considering that FDA will be transitioning to a new Commissioner).  At that point, pursuant to FDA’s announced extension, large and small tobacco product manufacturers must submit HPHC reports for their products by six and nine months, respectively, thereafter.

If you have any questions regarding HPHC reporting requirements contact Azim Chowdhury (chowdhury@khlaw.com). For more information about our Tobacco and E-vapor Practice, visit https://www.khlaw.com/evapor.

Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird discount!

FDA Regulation Update and Preparing for What’s Next
Azim Chowdhury

  • FDA’s New Announcement: How it Will Impact Your Business
  • Product Compliance Overview: Vapor, Cigars, Hookah
  • Flavors and Product Standards
  • Reporting on Harmful and Potentially Harmful Constituents (HPHCs)
  • Premarket Review for Deemed Tobacco Products
  • PMTAs, SE Reports, and Using Master Files
  • Potential Over-the-Counter Drug Pathway
  • Status of Proposed Rulemakings
  • Modified Risk Tobacco Products
  • Online Sales – “Heightened” Age-Verification
  • Retailer Compliance and Adults-Only Requirement
  • Enforcement and Penalties
  • …and much more!

FDA Inspections: Are You Prepared?
Azim Chowdhury and Daniel Rubenstein

  • Overview of FDA Inspection Authority
  • Update on Tobacco Product Manufacturing Practices
  • The FDA Inspection: Before, During and After
  • Enforcement and Penalties
  • Keller and Heckman’s Audit and Inspection Program (AIP)

Key Litigation Update
Eric Gotting

  • Nicopure and Right to be Smoke-Free Coalition v. FDA (Deeming Rule Appeal)
  • American Academy of Pediatrics v. FDA
  • Potential Upcoming Litigation (e.g., flavor and convenience store bans)

Environmental Issues Affecting Nicotine-Containing Products
JC Walker

  • Overview of Hazardous Waste Regulations Governing E-Liquid Manufacturers and Distributors
  • Considerations for Minimizing Regulatory Exposure

OSHA’s Hazard Communication Standard and Considerations for the E-Liquid Industry
Manesh Rath

  • Overview of OSHA’s Hazard Communication Standard (HCS)
  • Scope of Standard and Exemptions
  • Safety Data Sheets (SDSs)
  • Labeling
  • Employee Training
  • Future Challenges for E-liquid Industry

Advertising and Marketing: Implications for Global Public Policy and the Role of Self-Regulation
Sheila Millar

  • Marketing Practices: Impact on Public Perception, Regulations, Enforcement and Litigation
  • Expanding Global Concerns About Child-Appealing Marketing
  • Creating and Implementing Effective Advertising Self-Regulation

Business, IP, and Advertising Issues – How to Stay in Compliance                                       
Tracy Marshall and Bob Niemann

  • Drafting and Negotiating Vendor, Manufacturing, and Distribution Agreements
  • Insurance Policies for Vapor Companies
  • Protecting Trademarks, Copyrights, and Trade Secrets and Avoiding IP Infringement
  • Privacy and Data Security
  • Using Digital Marketing to Promote Your Business
  • Conducting Contests, Sweepstakes, and Other Promotions

State Law Update
Azim Chowdhury

  • Overview of State permit, licensing and tax requirements for tobacco and vapor products
  • Age-verification and delivery requirements

How to Sell Your Products in the EU (Without Getting into Problems): TPD and Beyond
Marcus Navin-Jones

  • Refresher on TPD Requirements
  • EU Requirements which Apply in Addition to the TPD
  • EU Law vs National Law: Areas where EU Countries are Allowed to Have their Own Rules
  • Recalls Withdrawals and Legal Crisis Management.
  • Brexit and How Brexit is Affecting the Vape Industry

Going International: Preparing Your Business for Global Compliance
David Ettinger

  • Current Regulatory Status of Vapor Products Around the World
  • China and Asia
  • New Zealand
  • Australia
  • Russia, India, Middle East, and More
  • World Health Organization

In addition to the topics above, we will also have special guest speakers from Cardno ChemRisk, Broughton Laboratories and others on topics including Premarket Tobacco Product Applications and HPHC Reporting. Stay tuned for the full agenda!

To register, click here.

Seminar Details:
Date: January 29 – 30, 2019
Cost: $899 if you register by January 4, 2019; $1,099 if you register after January 4, 2019
*register 3 or more attendees from the same company and receive a 10% discount. Email seminars@khlaw.com for additional information.

Continuing Legal Education (CLE)
CLE credits are available, pending state approval

Location
Marriott Miami Biscayne Bay
1633 N Bayshore Drive
Miami, FL 33132

Keller and Heckman has negotiated a preferred room rate of $259 per night, plus tax at the Marriott Miami Biscayne Bay. Reservations must be received no later than January 7, 2019. To make your reservation, please click here.

For additional information, please contact:

Sara A. Woldai, CMP
Manager, Marketing Meetings and Events
woldai@khlaw.com
202.434.4174

Photo of Azim ChowdhuryPhoto of Benjamin Wolf

 

 

Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along with copies of all labeling (see our full summary of the registration requirement here).  This registration must be renewed annually before midnight on December 31 (Eastern time) every year, and product lists must be updated bi-annually: by midnight June 30 and December 31 every year.

This means that operators of manufacturing establishments of newly deemed products (e.g., vapor, cigars, hookah, etc.) on the market as of August 8, 2016 that have made changes to their product offerings must update their product lists with FDA by tomorrow, June 30, 2018, or as soon as possible to avoid FDA enforcement (considering the likelihood that FURLS may crash, the sooner you start this process, the better). Specific examples of changes that need to be updated (in FURLS, if you used that system to register online) include (1) discontinuing products on your product list that you are no longer actively manufacturing, (2) adding new products that are now being manufactured (e.g., co-packers now manufacturing pre-August 8, 2016 products that were not on the co-packers’ initial product list), (3) adding a new manufacturing location for products already listed by another establishment, or (4) labeling changes (including rebranding) of existing products.

Note that if you are planning to update your labels to comply with FDA’s nicotine addiction warning and other labeling requirements (that go into effect on August 10, 2018) after June 30, you have until December 31, 2018 to update your product listing with the revised labels.

If you have any questions about Registration and Product Listing or any of the other Tobacco and Control Act requirements, contact Azim Chowdhury (202.434.4230, chowdhury@khlaw.com) or Ben Wolf (202.434.4103, wolf@khlaw.com). For more information on our Tobacco and E-vapor Practice in general, visit www.khlaw.com/evapor. Follow Keller and Heckman Tobacco and E-Vapor Partner Azim Chowdhury on Twitter.

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February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.

The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as amended by the Tobacco Control Act, which provides that FDA shall inspect each factory, warehouse, establishment, or vehicle in which tobacco products, including deemed tobacco products, are manufactured, processed, packed, or stored.  Pursuant to Sections 704 and 905 of the Act, FDA is directed to inspect every establishment at least once every two years.

Audit and Inspection Program

Keller and Heckman’s experienced team of attorneys and scientists will provide a comprehensive, on-site training and facility auditing program designed to help your company adequately prepare for an FDA inspection.  As part of the AIP, companies can expect:

  • An introductory presentation and memorandum detailing FDA’s inspection authority, what to expect during an inspection, and how to adequately prepare for – and respond to – an FDA inspection;
  • A full facility audit, consisting of a complete mock-inspection; and
  • A written post-inspection report detailing the overall readiness of the facility for an FDA inspection, including a list of specific recommendations and opportunities for improvement*

Keller and Heckman’s AIP program is designed to provide companies that are involved in any aspect of the tobacco or vapor product supply chain with confidence that their facilities are operating in accordance with FDA requirements.  The AIP will consider a broad range of inspection activities, including: recordkeeping, product labeling, product samples, requests for video/audio/photographic recordings, standard operating procedures, cleanliness and sanitation, inventory control, and personnel interviews.

Supplemental Environmental and OSHA Compliance Components

In addition to FDA compliance, the AIP offers companies the option to include supplemental compliance training and auditing focusing on environmental and occupational health and safety regulations and requirements – efficiently leveraging the FDA mock inspection and full facility audit.

  • Environmental: The AIP program will offer companies the opportunity to add an additional training and compliance component focusing on federal and state environmental and waste management regulations. Specifically, nicotine-bearing products may be subject to regulation under the Federal Resource Conservation and Recovery Act (RCRA) when disposed.  State regulations governing dangerous or industrial wastes also could apply.  This component will provide an overview of how nicotine in tobacco-based products are regulated differently than when found in e-cigarettes and other vaping products, and will provide valuable information regarding companies’ obligations in responding to these additional requirements.  For more information on environmental requirements, see here.
  • Occupational Health and Safety: Participants in the AIP program will also have the opportunity to add an additional training and compliance component focusing on federal and state Occupational Safety and Health laws. OSHA recordkeeping requirements apply to all employers, except very small businesses.  Most other OSHA standards apply to all employers, regardless of size.  This component will provide companies with a review of existing policies and practices, and will recommend specific actions designed to bring companies into compliance with regulations in areas relevant to the industry, including: personal protective equipment, emergency plans, fire protection, and hazard communication (g., labeling and safety data sheets).

Pre-Registration

Pre-registration for the AIP is available immediately by filling out the form available here:

Tobacco and Vapor Product Manufacturing Establishment Audit and Mock Inspection Program Pre-Registration Form

The completed pre-registration form can be E-mailed to chowdhury@khlaw.com, faxed to (202) 434-4646, or mailed to:

Keller and Heckman LLP
Attn: Azim Chowdhury
1001 G Street NW, Suite 500 West
Washington, D.C. 20001

Upon receipt of your pre-registration form, Keller and Heckman will provide your company with a formal written proposal and cost-estimate to conduct on-site training and mock inspection at your facility.  Scheduling is generally available on a first-come, first-serve basis.

*The written post-inspection report is covered by any existing attorney-client relationship between Keller and Heckman and the Company, and is generally not subject to discovery.  The recommendations set forth in the post-inspection report are for informational purposes only, and do not constitute any warranties or guarantees regarding the outcome of an actual FDA, EPA or OSHA inspection.  Keller and Heckman’s attorneys remain available and look forward to the opportunity to assist with any post-inspection activities or questions following completion of the written report.